Lonza America Inc

Manager, Product Development GMP Operations

Lonza America Inc$100K — $130K *
Tampa, FL 33647In-Person
Pharmaceuticals & Biotech
11 - 15 years of experience
Job Overview by Ladders

Qualifications

  • 5-7 years of experience in early-phase GMP drug product manufacturing/packaging.
  • Strong understanding of cGMP regulations and quality systems.
  • Proven leadership abilities in managing technical teams and resolving complex issues.
  • Experience in designing or supporting GMP facilities and engineering activities.
  • Excellent communication and stakeholder management skills.
  • A scientific degree is required, preferably in a relevant field.
  • 15+ years of experience with a bachelor's or master's degree, or 10+ years with a PhD.

Responsibilities

  • Lead Product Development GMP manufacturing and packaging operations for early-phase clinical trials.
  • Oversee the design and maintenance of PD GMP spaces, including equipment selection.
  • Serve as the technical and operational Subject Matter Expert for PD GMP activities.
  • Provide leadership and management for a diverse technical team, focusing on development.
  • Ensure compliance with cGMPs, SOPs, safety standards, and maintain inspection readiness.
  • Act as a key stakeholder in regulatory audits, client meetings, and site visits.
  • Coordinate closely with cross-functional teams to ensure timely project delivery.

Benefits

  • Opportunities for growth in a dynamic Product Development environment.
  • Collaborative, inclusive, and ethical workplace culture.
  • Compensation programs recognizing high performance and leadership impact.
  • Competitive medical, dental, and vision insurance coverage.
  • Access to learning, development, and leadership programs at Lonza.
Full Job Description
Job Title
Manager, Product Development GMP Operations

Location
Tampa, FL, USA

The actual location of this job is in Tampa, FL. Relocation assistance is available for eligible candidates and their families, if needed.

The Manager, Product Development GMP Operations is a site-based leadership role supporting early-phase clinical trial drug product manufacturing and packaging. This position offers the opportunity to design and lead GMP capabilities, guide multidisciplinary teams, and directly contribute to bringing innovative therapies into the clinic.

What you will get
  • An agile career with opportunities for growth in a dynamic Product Development environment
  • A collaborative, inclusive, and ethical workplace culture
  • Compensation programs that recognize high performance and leadership impact
  • Competitive medical, dental, and vision insurance coverage
  • Access to Lonza's learning, development, and leadership programs


What you will do:
  • Lead and develop Product Development GMP manufacturing and packaging operations supporting early-phase clinical trial drug products
  • Design, oversee, and maintain PD GMP spaces, including equipment selection, engineering build-outs, and approval of engineering drawings
  • Serve as the technical and operational SME for PD GMP activities, supporting projects, new technologies, and strategic growth initiatives
  • Provide leadership and administrative management for a diverse technical team, including performance reviews, coaching, training, and career development
  • Ensure compliance with cGMPs, SOPs, safety standards, and regulatory requirements, maintaining inspection readiness at all times
  • Act as a key internal and external stakeholder, participating in regulatory audits, client meetings, and on-site visits
  • Coordinate closely with engineering, quality, manufacturing, and project teams to ensure timely, compliant, and cost-effective delivery of work


What we are looking for:
  • Significant experience in early-phase GMP drug product manufacturing and/or packaging within a pharmaceutical or life sciences environment
  • Strong understanding of cGMP regulations, quality systems, regulatory inspections, and audit readiness
  • Proven ability to lead technical teams, manage resources, resolve complex issues, and deliver results through others
  • Experience designing or supporting GMP facilities, including collaboration with engineering and oversight of build-out activities
  • Effective communication and stakeholder management skills, including customer-facing and cross-functional collaboration
  • A scientific degree or similar field required, with an emphasis on applying knowledge to advance drug product development
  • Approximately 15+ years of relevant experience with a bachelor's or master's degree, or 10+ years with a PhD


Ready to shape the future of life sciences? Apply now.

About Lonza America Inc

Lonza America Inc is a subsidiary of Lonza Group, a Swiss multinational company that provides products and services to the pharmaceutical, biotech, and specialty ingredients markets. Lonza America Inc is responsible for the North American market and offers a range of products and services, including custom manufacturing, research and development, and quality control testing. The company has a strong focus on sustainability and has implemented various initiatives to reduce its environmental impact. Lonza America Inc was founded in 1897 and has since grown to become a leading provider of products and services in the pharmaceutical and biotech industries.
Learn more about Lonza America Inc
Size
16,218 employees
Industry
NASDAQ

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